Pilot Study Investigating the Metabolic Activity and Transcriptional Profiling in Vivo in Tumor Biopsies in Melanoma Patients During Treatment With Pazopanib Alone and in Combination With Paclitaxel

This study is currently recruiting participants.
Verified August 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01666418
First received: August 8, 2012
Last updated: August 15, 2012
Last verified: August 2012

August 8, 2012
August 15, 2012
August 2012
December 2013   (final data collection date for primary outcome measure)
Evaluation of metabolic activity in vivo [ Time Frame: 84 days ( Baseline, Day 10, Day 70) ] [ Designated as safety issue: No ]
The primary efficacy objective is to evaluate the metabolic activity in vivo through standardising the uptake value (SUV) in the FDG-PET/CT in comparison of the SUV between baseline, after pazopanib alone (day 10) and after pazopanib plus paclitaxel (day 70).
Same as current
Complete list of historical versions of study NCT01666418 on ClinicalTrials.gov Archive Site
  • Determination of changes in gene expression profiling [ Time Frame: 84 days ( Baseline, Day 10, Day 70) ] [ Designated as safety issue: No ]
    Determination of changes in gene expression profiling on exon level in all patients with (sub)-cutaneous or superficial lymph node metastases (of melanoma) during pazopanib and pazopanib plus paclitaxel therapy in comparison to pretreatment profile
  • Evaluation of the antitumor activity of the combination in terms of progression free survival (PFS) [ Time Frame: 112 days ] [ Designated as safety issue: No ]
  • Changes in S100 and LDH during therapy at the same time points as FDG-PET/CT (a combined serum measurement of S100 and LDH) [ Time Frame: 84 days ( Baseline, Day 10, Day 70) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pilot Study Investigating the Metabolic Activity and Transcriptional Profiling in Vivo in Tumor Biopsies in Melanoma Patients During Treatment With Pazopanib Alone and in Combination With Paclitaxel
Not Provided

This is an open, monocentric, pilot study to determine the metabolic activity (glucose-uptake) in vivo during monotherapy with pazopanib in comparison to combination therapy with pazopanib plus paclitaxel and to investigate the transcriptional profile of cutaneous melanoma metastasis before and during the therapy (pazopanib vs. pazopanib plus paclitaxel) in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy.

Primary Objective:

Evaluation of metabolic activity in vivo

Secondary Objective:

Determination of changes in gene expression profiling Evaluation of the antitumor activity of the combination in terms of progression free survival (PFS). Changes in S100 and LDH during therapy at the same time points as FDG-PET/CT (a combined serum measurement of S100 and LDH)

  • Trial with medicinal product
Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
Drug: Pazopanib/Paclitaxel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Age ≥ 18 years
  • Diagnosis of histologically or cytologically confirmed melanoma stage III or IV.
  • Fresh tumor tissue must be provided for all subjects for biomarker analysis before (within 14 days prior to treatment start) and during (on day 10 of the pazopanib monotherapy and the last day of the treatment with pazopanib, day 70) treatment with investigational product (asservation in RNAlater, for kryo asservation, and for cell cultures)
  • Assessable metastases (skin or superficial lymph nodes with a minimal diameter 1 cm)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ system function

Exclusion criteria:

  • Prior malignancy.
  • Central nervous system (CNS) metastases
  • Corrected QT interval (QTc) > 480 msecs using Bazett's formula.
  • History of any one or more of the following cardiovascular conditions within the past 6 months:

    • Cardiac angioplasty or stenting;
    • Myocardial infarction;
    • Unstable angina;
    • Coronary artery bypass graft surgery;
    • Symptomatic peripheral vascular disease;
    • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
  • Poorly controlled hypertension
  • History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  • Presence of uncontrolled infection
  • Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding
  • Evidence of active bleeding or bleeding diathesis
  • Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
  • Prior exposure to the study drug pazopanib
Both
18 Years and older
No
Contact: Jil Dreier jil.dreier@usz.ch
Contact: Reinhard Dummer, Professor, MD reinhard.dummer@usz.ch
Switzerland
 
NCT01666418
SZ10ON01
Not Provided
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Reinhard Dummer, Professor MD University Hospital Zurich, Division of Dermatology
University of Zurich
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP